Important interpretation

1

Ministry of Commerce, General Administration of Customs, National Medical Products Administration Announcement No. 5 (2020), Announcement on the Orderly Development of the Export of Medical Supplies

Starting from April 1, companies that export new coronavirus testing reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers must provide a written or electronic declaration to the customs to declare that their exported products have obtained my country’s medical device product registration. The certificate meets the quality standard requirements of the importing country (region). The customs shall inspect and release the medical device product registration certificate approved by the drug supervision and administration department. The above-mentioned medical material export quality supervision measures will be dynamically adjusted according to the development of the epidemic situation. 2

Regarding the qualifications and materials required for preparing a trading company before export

Qualifications and materials required by domestic export trading companies:

1. China Customs requires:

Medical device registration certificate (not required for non-medical devices)

2. Foreign customers may request to provide (specifically subject to the requirements of the foreign importer or the destination country, China Customs does not charge it, and does not need to be attached to the declaration): 1. Business license (the business scope has relevant business content).

2. Enterprise production license (manufacturing enterprise).

3. Product inspection report (manufacturing enterprise).

4. Product manual (provided with the product), label (provided with the product).

5. Product batch/number (outer packaging).

6. Product quality and safety certificate or certificate (provided with the product).

7. Product sample pictures and outer packaging pictures.

3

About medical device business qualification

The customs has no requirements for medical device operating qualifications, and there is no need to attach it when making export declarations.

4

About the classification of test reagents

Common new coronavirus (2019-nCoV) nucleic acid detection kit (fluorescence PCR method), new coronavirus (2019-nCoV) nucleic acid detection kit (constant temperature amplification-real-time fluorescence method), new coronavirus (2019-nCoV) Nucleic acid detection kit (combined probe-anchored polymerization sequencing method) and novel coronavirus (2019-nCoV) antibody detection kit (magnetic particle chemiluminescence method) are included in 3822090;

The new coronavirus (2019-nCoV) IgG antibody detection kit (magnetic particle chemiluminescence method) and the new coronavirus (2019-nCoV) IgM/IgG antibody detection kit (colloidal gold method) are included in 30021500.

New coronavirus detection kits have many detection methods, and new methods are constantly appearing. Its classification requires comprehensive judgment based on the components contained in the kit and the detection principle.

When importing and exporting companies refer to the above-mentioned tax numbers, they should not only rely on the product names of the kits to judge, but also correspond to the ingredients and detection principles of the above-mentioned commodities.

5 Update on the relaxation of the access of protective materials in the United States

On March 28, the U.S. Food and Drug Administration (FDA) explained the scope of emergency use authorization (EUA) related to masks as follows. This authorization is limited to the products listed in the following table, and the authorized purification method meets the conditions in the following table In the case of the outbreak of the new crown epidemic and the shortage of related materials, it will be used as a recommended product by the Centers for Disease Control and Prevention (CDC) for medical personnel to avoid contact with airborne pathogenic particles.

Consultation Q&A

Q: Are there any requirements for the consignor for the export of test reagents? Can ordinary trading companies be engaged in the export of these businesses? Or must it be a trading company with medical device operating qualifications?

A: The consignor only needs to obtain the registration code of the customs consignee and consignor, and there is no special requirement.

Q: What is the difference between the application for sanitation and quarantine approval and the declaration of export legal inspection goods in the export customs clearance requirements in the test reagent article? Thank you

A: There are two links. Sanitation and quarantine approval is a prerequisite for the declaration of reagents for legal inspection. The export of test reagents needs to apply for sanitation and quarantine approval first, and then apply for export inspection and quarantine at the single window.

Q: Hello, please help me to confirm, in the European Union, does the new crown colloidal gold test (antibody test) belong to the category A or the last category IVDD others with the lowest risk level?

A: The new coronavirus detection reagents belong to Appendix 11 Class A (microbial antigens, antibodies, nucleic acid detection reagents, blood group reagents).

Q: Are there any special requirements for the export of reagents for import and export companies?

A: The customs has no special requirements, but such products belong to legal inspection products and require sanitary quarantine approval.

Q: 6 categories of dangerous goods also mentioned that this biological product testing reagent is considered dangerous goods?

A: The detection reagents are in vitro diagnostic reagents, not dangerous goods.

Q: Is the detection kit for the new coronavirus colloidal gold also a nucleic acid detection kit?

A: Generally colloidal gold is an antibody detection kit.

Q: Many foreign companies in China now need to purchase masks in China to donate them to foreign companies in the same group. 1. Can donated materials be used for supervision? 2. If the donated materials can be used in the name, does the company still need to change the business scope?

A: In this case, the supervision method should be "other import and export free", and the customs has no requirements on the scope of business.

Q: Do domestic trading companies have to apply for the domestic second-class medical device business registration certificate for exporting medical masks?

A: The customs has no such requirement.

Q: For pure export, the trading company does not need a second-class medical device business license?

A: The customs has no requirements on business qualifications.

Q: The trading company exports medical masks. According to the first point of "Business license (business scope with relevant business content)" in the "Qualifications and Materials Needed by Domestic Export Trade Enterprises" above, understand whether the trading company's business scope should be clearly stated Is it possible to operate medical equipment?

A: The "Business License" is not a document that China Customs needs to collect, and it does not need to be attached to the Customs for export declaration. The customs has no requirements on business scope.

Q: Excuse me, domestic companies donate export masks to foreign companies or individuals. The export method is: Donated materials? Other import and export free? Thank you!

A: Other import and export are free

Q: Does the business scope of the domestic shipper (business unit) have to include the words "Import and Export of Labor Insurance Products" before they can be exported? If the "labor insurance products" are not reflected in the business scope, and the production and sales unit (manufacturer) has it in the business scope, it can also be exported?

A: The customs has no requirements on the business scope of the consignor.

Q: What is the CE certification of the disinfectant? Many certification companies indicate that it is not within the scope of certification

A: The products under the CE-certified medical device directive include chemical disinfectants and sterilants, and the directive code is 93/42/EEC. If there is any update and change, please consult the importer or the official CE certification body of the European Union for details.

Q: Does the quaternary ammonium salt-based hand sanitizer mainly composed of benzalkonium chloride need to be FDA registered?

A: Most of the hand sanitizers sold in the United States are regulated as medicines rather than cosmetics. Therefore, quaternary ammonium salt-based hand sanitizers mainly composed of benzalkonium chloride also need to be registered with the FDA. If there are updates and changes, the specific circumstances Please consult the importer or US official agency.

Q: I would like to ask. For example, production company A wants to export medical masks, and it has a medical device license and registration certificate, but it does not have the right to export. Can we entrust company B to export? Company B has the right to export, but it does not have the medical device registration certificate and license (during the process, it just didn’t come out so quickly). Company B’s business scope: it can produce medical masks and also has import and export rights, but there is no agent in the business scope. For export business, can we act as an agent in this way?

A: Can be an agent

(Source: Guanwu Primary 2)